Botox Injection in Treatment of Chronic Migraine
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
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Trondheim, Norge
- Department of Neuroscience, Norwegian University of Science and Technology
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Informed and written consent
- Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Failed at least 3 oral migraine prophylactic treatments
- Duration of migraine at least 1 year before inclusion
- Start of migraine before participant turned 50 years
- Participant can make a distinction between migraine and other types of headache
Exclusion Criteria:
- If the criteria for medication-overuse headache (MOH) is fulfilled
- Heart or lung disease
- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- Psychiatric illness that hinders participation in the study
- Known pregnancy or breast feeding
- Inadequate use of contraceptives
- Overuse or abuse of opioids
- Abuse of medications, narcotics or alcohol
- Anomalies which hinder or impede the used method of injection
- Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
- Treatment with medication that can interact with botulinum toxin type A
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Botulinum Toxin
The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of adverse events and number of participants with adverse events
Tidsram: For the follow-up period of 3 months
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Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used.
Registration of any adverse events categorized by probable relationship to drug or the procedure.
Data obtained from the headache diaries as well as open questions during consultations.
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For the follow-up period of 3 months
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Number of headache days with moderate or severe intensity
Tidsram: 5-8 weeks
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measured from week 5 to week 8, in total during 4 weeks
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5-8 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of reponders
Tidsram: 12 weeks
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response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
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12 weeks
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Days with moderate or severe headache per 4 weeks
Tidsram: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Days without headache per 4 weeks
Tidsram: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Hours with headache of moderate or severe headache per 4 weeks
Tidsram: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Erling A Tronvik, PhD, MD, Norwegian University of Science and Technology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Huvudvärk, primär
- Huvudvärk
- Migränstörningar
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Kolinerga medel
- Membrantransportmodulatorer
- Acetylkolinfrisättningshämmare
- Neuromuskulära medel
- Botulinumtoxiner
- Botulinumtoxiner, typ A
- abobotulinumtoxinA
Andra studie-ID-nummer
- BTACM2014
- 2014-001852-43 (EudraCT-nummer)
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